Human-Machine System for the H2 Lower Limb Exoskeleton

Conditions

• Hemiparesis
• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Robot-assisted training with the H2 lower limb powered exoskeleton — BEHAVIORAL
  The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.
• Supervised motor practice — BEHAVIORAL
  Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.

Study Details

This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.

Key Dates

Start date

Nov 20, 2015

Status verified

Oct 2024

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Robot-assisted Rehabilitation
  Participants will receive Robot-assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours.
• Active Comparator: Supervised motor practice
  Participants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours.

Primary Outcome Measure

Change from baseline in Fugl-Meyer Assessment - Lower Extremity Motor Function [ Time Frame: Baseline, Post-Intervention (within a week of completion), Follow-up at 2 weeks, Follow-up at 2 months ]

Central Contacts

• Jose L Contreras-Vidal, PhD
  713-743-4429
  [email protected]

Locations (2)

Find similar trials in Houston, TX

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